Full TitlePhase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) as Monotherapy and with Chemotherapy in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies
The purpose of this study is to find the highest dose of the investigational drug MVT-5873 that can be given alone and in combination with standard chemotherapy in patients with pancreatic cancer and other tumors that contain the CA19-9 protein. MVT-5873 is designed to kill cancer by targeting CA19-9, a protein on the surface of these cancer cells.
Patients whose pancreatic cancer came back after prior treatment will receive MVT-5873 alone. Those whose cancer has not yet been treated will receive MVT-5873 plus the standard chemotherapy drugs nab-paclitaxel and gemcitabine. All of these drugs are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have pancreatic cancer or another tumor that is positive for CA19-9.
- For patients who had prior treatment, at least 4 weeks must pass between completion of previous therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.